Senior Manager Clinical Management

Posted by: Otsuka

Posted date: Feb-22-2012

Location: Princeton, NJ 08510

Job Description:

Provides leadership and day-to-day guidance to internal and External Service Provider (ESP) study team for all protocols within an assigned program. Ensures cross-study consistency in protocol design, data analysis and reporting. Responsible for the development of clinical protocols concepts to support the company's product strategy. Interacts with expert physicians, investigators, ESP personnel, and functional area staff to ensure program strategy and objectives are understood and implemented and to address program related issues and questions.

Responsibilities:

•Ensures compliance with FDA and international regulations, GCPs, and SOPs. Develops presentations and reports for Senior Management.

•Acts as the operational lead for a global program (indication, formulation, phase, or other set of related clinical trials), or for multiple clinical programs. Provides guidance to Clinical Trial Leads working within assigned program and ensures operational consistency across assigned clinical trials.

•Serves as a secondary contact for ESP, where Clinical Trial Lead serves as the primary contact.

•Oversees ESP personnel in the development of protocols, amendments, CRFs and other study-related documents. Under the direction of the clinical team, writes protocol outlines, protocols, amendments, and other documents.

•Acts as final reviewer of proposed investigator list for clinical studies

•Communicates and coordinates program-related activities across all relevant cross-functional areas.

•In collaboration with the protocol team, leads the clinical trial data ongoing medical/scientific review focusing on data integrity, trending & consistency across the program. Contribute to final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.

•Serves as member of program level teams including GBT/PDC /JDC/Alliance teams and presents to program level updates to senior management and team.

•Provides clinical research operational expertise in the development of the GCDP, including performing/overseeing and providing background research(literature, SBA, competitive intelligence, regulatory guidance etc).

•Supports ongoing competitive intelligence for program, providing a written or slide summary of findings, as requested.

•Works with various groups to devise training program(s) for the employee and makes arrangements for such sessions to be conducted. Ensures the employee has access to all required material, systems to satisfy their individual job responsibilities.

•Assures compliance with departmental, SOP, compliance and corporate training for all direct reports.

•Participates in ESP partnership governance and alliance management activities as assigned, within and across programs and portfolios.

Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of Otsuka's ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of its patients around the world with a strong commitment to research and development in the areas of cardiovascular, respiratory, renal and neuroscience systems, and to treat cancer and ophthalmic disorders.